# PMS: Peripheral Intravenous (Piv) Infiltration Monitor

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 64 days (middle half 47–81)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2020: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K162478: ivWatch (2016), cited by 2
- K153605: ivWatch Model 400 (2016), cited by 1
- K192385: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (2020), cited by 1

Source page: https://510kreport.com/product-code/PMS
Data by year (CSV): https://510kreport.com/product-code/PMS.csv